The Wire-free Invasive Functional Imaging (WIFI) Study (WIFI)

Feasibility of On-line Computed Fractional Flow Reserve: The Wire-free Invasive Functional Imaging (WIFI) Study

Quantitative Flow Ratio (QFR) is a new method for evaluating the functional significance of coronary stenosis by calculation of the pressure in the vessel based on two angiographic projections. The purpose of the WIFI study is to evaluate feasibility of QFR when performed during coronary angiography and compare diagnostic accuracy to standard FFR.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: QFR (observational)

Detailed Description

Background:

Patients at high risk of having one or more coronary stenosis are evaluated routinely by invasive coronary angiography (CAG) and often in combination with measurement of fractional flow reserve (FFR) to assess the functional significance of identified stenosis. FFR is assessed during CAG by advancing a wire with a pressure transducer towards the stenosis and measure the ratio in pressure between the two sides of the stenosis during maximum blood flow (hyperaemia) induced by adenosine infusion.

The solid evidence for FFR evaluation of coronary stenosis and the relative simplicity in performing the measurements have supported adoption of an FFR based strategy in many centers but the need for interrogating the stenosis by a pressure wire and the cost of the wire and the drug inducing hyperaemia limits more widespread adoption.

Quantitative Flow Ratio is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure in the vessel based on two angiographic projections.

The purpose of the WIFI study is to evaluate feasibility of QFR when performed during coronary angiography and compare diagnostic accuracy to standard FFR.

Hypothesis:

QFR can be assessed during CAG for stenosis interrogated by FFR

Methods:

Proof-of-concept, prospective, observational, single arm study with inclusion of 100 patients. Clinical follow-up by telephone call after one year.

A stenosis with indication for FFR is identified and at least two angiographic projections rotated at least 25 degrees around the target vessel are acquired during resting conditions. QFR is calculated on-line using the Medis Suite application and simultaneously to the operator performing the FFR measurement using I.V. adenosine. The QFR observer is blinded to the FFR measurement.

QFR is reassessed off-line by internal observer and by an external core laboratory. Both blinded to FFR results.

FFR is assessed in core laboratory by a different blinded observer

All data are entered and stored in a protected and logged trial management system (TrialPartner).

• Study Type: Observational
• Enrollment (Actual): 99

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Aarhus University Hspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with stable angina pectoris admitted for coronary angiography due to high risk of significant coronary stenosis.

Description

Inclusion Criteria:

• Stable angina pectoris and secondary evaluation of stenosis after acute myocardial infarction (AMI)
• Age > 18 years
• Signed informed consent

Exclusion Criteria:

• Myocardial infarction within 72 hours
• Severe asthma and chronic obstructive pulmonary disease
• Severe heart failure (NYHA≥III)
• S-creatinine>120µmol/L
• Allergy to contrast media or adenosine
• Stenosis in vein graft
• Ostial left main stenosis
• Severe tortuosity
• Atrial fibrillation

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
QFR group; Patients with stable angina pectoris and indication for FFR.	Other: QFR (observational); QFR assessment by Medis Suite, Medis medical imaging B.V., The Netherlands

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of in-procedure QFR	Percentage of successful QFR in FFR-cases.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with positive QFR of FFR positive patients (true positives) (sensitivity)	Positive FFR is defined as FFR≤0.80. Positive QFR is defined as QFR≤0.80	1 hour
Proportion of patients with negative QFR of patients with negative FFR (true negatives) (specificity)	Negative FFR is defined as FFR>0.80. Negative QFR is defined as QFR>0.80	1 hour
Proportion of patients with positive FFR (true positives) of patients with positive QFR (positive predictive value)	Positive FFR is defined as FFR≤0.80. Positive QFR is defined as QFR≤0.80	1 hour
Proportion of patients with negative FFR (true negatives) of patients with negative QFR (negative predictive value)	Negative FFR is defined as FFR>0.80. Negative QFR is defined as QFR>0.80	1 hour
Diagnostic performance of QFR in comparison to FFR reported as positive and negative likelihood ratio		1 hour
Diagnostic accuracy of QFR in comparison to 2D quantitative coronary angiography (QCA) (>50% diameter stenosis)	Defined as area under the receiver operating curve (ROC)	1 hour
Diagnostic accuracy of QFR based on fixed hyperemic flow rate (in-procedure analysis)	Defined as area under the receiver operating curve (ROC)	1 hour
Diagnostic accuracy of QFR based on Thrombolysis in Myocardial Infarction(TIMI) flow without hyperemia (in-procedure analysis)	Defined as area under the receiver operating curve (ROC)	1 hour
Diagnostic accuracy of QFR based on TIMI flow with hyperemia (core laboratory analysis)	Defined as area under the receiver operating curve (ROC)	1 hour
Any QFR procedure-related adverse events/complications (safety)	Death, myocardial infarction, acute renal failure clearly related to additional angiographic projections.	1 hour
Time to FFR	From last diagnostic angiogram before advancing FFR-wire to approved drift-check	1 hour
Time to QFR	From receiving angiographic images to QFR-value	1 hour
Contrast use	Volume of contrast for total procedure	1 hour
Fluoroscopy time		1 hour
Myocardial infarction	Universal definition	1 year
Target lesion failure	Universal definition	1 year
Target lesion revascularization	Universal definition	1 year
Stent thrombosis	Universal definition	1 year
Angina pectoris	Canadian Cardiovascular Society (CCS)-class	1 year
Cardiac death	Universal definition	1 year
Non-cardiac death	Universal definition	1 year

Collaborators and Investigators

• Sponsor: Niels Ramsing Holm
• Investigators: Principal Investigator: Niels R. Holm, M.D., Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2016
• Primary Completion (Actual): June 6, 2016
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: April 29, 2016
• First Submitted That Met QC Criteria: June 9, 2016
• First Posted (Estimate): June 10, 2016

Study Record Updates

• Last Update Posted (Actual): June 19, 2019
• Last Update Submitted That Met QC Criteria: June 18, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Fractional Flow Reserve
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 1-10-72-272-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED